By Olindo Lazzaro, Michael Gallagher, and Max Brescia
For drug manufacturers, patient safety is of the utmost concern, and efforts to prevent cross contamination of highly potent active pharmaceutical ingredient (HPAPI) are a critical part of a safe manufacturing process. Likewise, the safety of workers who make the drug products, and the environment in which they work, is also paramount, particularly when manufacturing with high containment compounds. Inadequate containment of these compounds can put patients, employees, and the environment at increased risk, while decreasing product yields. Manufacturing costs can also rise with additional requirements for personal protective equipment and medical surveillance for workers, or for pollution controls and special housekeeping for manufacturing areas.
To ensure that employee exposures are kept within accepted limits and protect the environment while containing costs, pharmaceutical companies and their contract partners who manufacture and handle high containment compounds must carefully select equipment, outline processes and procedures, and deploy appropriate containment technologies.
Applying engineering controls in the manufacturing process reduces the risk of contamination of the manufacturing environment and is the preferred method of controlling employee exposure. Occupational hygiene monitoring techniques and methods of analysis can then be used to verify the performance of the engineering controls. Separate guidelines are required for the design and construction of the facilities in which high containment compounds are handled.